EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis

Medanta, The Medicity, India

Status: Enrolling

Conditions: Cirrhosis; Gastric Varices Bleeding

Treatments: Procedure: EUS-guided Coil and Cyanoacrylate Glue Injection; Procedure: Endoscopic Cyanoacrylate Glue Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07855913

MED-END-GV-2026-001

Details and patient eligibility

About

Gastric variceal bleeding is a life-threatening complication of portal hypertension in patients with cirrhosis and is associated with significant morbidity and mortality. Endoscopic cyanoacrylate glue injection is the current standard treatment; however, recurrent bleeding and procedure-related complications remain important concerns. Endoscopic ultrasound (EUS)-guided coil and cyanoacrylate glue injection has emerged as a promising alternative that may improve variceal obliteration and reduce rebleeding rates.

This prospective, randomized, open-label, parallel-group trial will compare EUS-guided coil and cyanoacrylate glue injection with conventional endoscopic cyanoacrylate glue injection in patients with cirrhosis presenting with bleeding gastric varices. A total of 158 participants will be randomized in a 1:1 ratio to either treatment arm. The primary outcome is all-cause rebleeding at 12 months. Secondary outcomes include technical success, early and late rebleeding, number of treatment sessions required for variceal obliteration, glue volume used, procedure-related adverse events, hepatic decompensation, duration of hospital stay, cost of treatment, and mortality.

Full description

Gastric varices (GV) are a major complication of portal hypertension in patients with cirrhosis and account for approximately 10-30% of all variceal bleeding episodes. Although less common than esophageal variceal bleeding, gastric variceal hemorrhage is often more severe and is associated with higher transfusion requirements, increased risk of rebleeding, and significant mortality. Endoscopic injection of cyanoacrylate (CYA) glue is currently the standard endoscopic treatment for bleeding gastric varices and has demonstrated high rates of initial hemostasis. However, recurrent bleeding, incomplete obliteration of varices, glue extrusion, embolic complications, and the need for repeated treatment sessions remain important limitations.

Endoscopic ultrasound (EUS)-guided therapy has emerged as an alternative approach for the management of gastric varices. EUS enables precise visualization of gastric varices and their feeding vessels, facilitating targeted treatment. The combination of EUS-guided coil deployment and cyanoacrylate glue injection may improve variceal obliteration by providing a scaffold for glue retention, reducing glue requirements, and minimizing the risk of embolization. Several observational studies and meta-analyses have suggested that EUS-guided coil and glue therapy may achieve superior variceal obliteration and lower rebleeding rates compared with conventional endoscopic glue injection. However, high-quality randomized controlled trials comparing these approaches remain limited.

This study is a prospective, randomized, open-label, parallel-group clinical trial designed to compare the efficacy and safety of EUS-guided coil and cyanoacrylate glue injection with conventional endoscopic cyanoacrylate glue injection in patients with cirrhosis presenting with bleeding gastric varices. A total of 158 eligible participants will be enrolled and randomized in a 1:1 ratio to one of two treatment groups. Participants assigned to the intervention arm will undergo EUS-guided deployment of embolization coils followed by cyanoacrylate glue injection into the target gastric varix. Participants assigned to the comparator arm will undergo direct endoscopic cyanoacrylate glue injection according to standard practice. Follow-up endoscopic or EUS assessments will be performed as per protocol, and repeat treatment sessions will be undertaken when necessary until complete obliteration of the varices is achieved.

The primary objective of the study is to compare all-cause rebleeding at 12 months between the two treatment strategies. Secondary objectives include assessment of technical success, early and late rebleeding, number of treatment sessions required for complete variceal obliteration, volume of cyanoacrylate glue utilized, procedure-related adverse events, hepatic decompensation, duration of hospital stay, treatment-related costs, and mortality.

Participants will be followed for a period of 12 months after randomization. The findings of this study are expected to provide robust evidence regarding the optimal endoscopic management strategy for bleeding gastric varices and may help guide future clinical practice in patients with portal hypertension and cirrhosis.

Enrollment: 110 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Confirmed diagnosis of liver cirrhosis with portal hypertension
• Patients presenting with suspected bleed from cardio-fundal varices, specifically classified as gastroesophageal varices type-2 (GOV-2) or isolated gastric varices type-1 (IGV-1)

Exclusion criteria

• Patients experiencing bleeding from esophageal varices (EV) or gastroesophageal varices type-1 (GOV-1) or IGV2
• Patients with non-cirrhotic portal hypertension
• Active spurt of blood noted from gastric varices seen on endoscopy
• Pregnancy
• Patients with refractory shock
• Sepsis/ACLF
• Platelet count < 50,000 /mL and International Normalized Rate (INR) > 2.0
• Contraindication to endoscopy
• Not willing to provide consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

EUS-guided Coil and Glue Injection

Experimental group

Description:

Participants randomized to this arm will undergo endoscopic ultrasound (EUS)-guided treatment of bleeding gastric varices using embolization coils followed by cyanoacrylate glue injection. Additional EUS-guided treatment will be performed during follow-up if residual Doppler flow is present until complete variceal obliteration is achieved. Participants will undergo scheduled follow-up for 12 months with clinical assessment, EUS surveillance, and laboratory investigations.

Treatment:

Procedure: EUS-guided Coil and Cyanoacrylate Glue Injection

Endoscopic Glue Injection

Active Comparator group

Description:

Participants randomized to this arm will undergo conventional endoscopic cyanoacrylate glue injection for treatment of bleeding gastric varices. Additional endoscopic glue injection will be performed during follow-up if residual varices are present until complete variceal obliteration is achieved. Participants will undergo scheduled follow-up for 12 months with clinical assessment, surveillance endoscopy, and laboratory investigations.

Treatment:

Procedure: Endoscopic Cyanoacrylate Glue Injection